Orthopedic brace and component for use therewith

ABSTRACT

An orthopedic device includes a rigid frame assembly having rigid frame supports connected by joints. The device also includes a strap which extends between sides of the frame assembly. An orthopedic component in the form of a resilient subshell is connected to and extending flexibly outwardly from the frame assembly. The subshell has a main body and a perimeter edge portion secured along the periphery of the main body wherein the perimeter edge portion is formed from a material having less hardness than a material used to form the main body. The strap is connected to at least one end portion of the subshell.

This application claims the benefit of priority from U.S. provisionalapplication 60/900,719 filed on Feb. 12, 2007.

TECHNICAL FIELD

The present invention generally relates to orthopedic braces, and moreparticularly to an orthopedic brace including flexible and ventilatedcomponents or subshells possessing discrete regions having superiorpressure-relieving properties and different degrees of flexibility.

BACKGROUND

Orthopedic braces comprise a broad range of structures and devices usedfor supporting or stabilizing a joint when worn on the body of a user.Orthopedic braces may serve in either preventative or remedial roles. Inthe preventative role, the brace can provide additional support,stability and protection to a healthy joint so as to prevent or minimizeinjury to the joint due to undue stress. On the other hand, in theremedial role, the brace can support and strengthen a weakened joint dueto injury or infirmity, and thereby reinforce the joint to preventfurther injury, or correct or assist the infirmity.

Typically, orthopedic braces include a frame that comprises at least onesupport member. When there are multiple support members, the brace mayinclude rotational hinges that assist and control movement of the limb.Suitable straps may be used to maintain the brace on the limb, and otherfeatures such as pads may be used to relieve pressure of the brace onthe limb and surrounding areas.

A predominant type of orthopedic brace is a knee brace. Knee braces areused to stabilize the knee by preventing excessive movement of the knee,or to facilitate movement of the knee. Many braces comprise a frame andhave hinges located on at least one of the lateral and medial sides ofthe knee joint. Straps are used to secure the brace to the leg or knee.An injured knee can be fit with an “off the shelf” brace or a“custom-fit” brace, with the selection of the type of brace depending onthe size and shape of an individual's leg.

Many knee braces are designed to reduce knee instability following aninjury, fatigue or to treat impairment of the knee, particularly if theknee has damaged ligaments. Braces may be recommended for walking,skiing, running, twisting, pivoting, or jumping activities. In additionto providing increased stability to the knee, braces may also decreasethe risk of injuring the knee or leg, or provide corrective assistanceto the knee. One way of protecting the knee is by including attachmentssuch as a patella protector assembly which may be secured onto the braceand configured to operate to protect the patella impact during physicalactivities.

In order to maximize its supportive, protective and comfort aspects, itis desirable that a knee brace securely and precisely fit the leg of thewearer. While custom-fit braces are made to closely conform to the exactgeometry of a leg of a wearer, it is common for the geometry of the legto change over time thereby requiring even a custom-fit to be able toaccommodate a variety of geometries of the leg. As for off-the-shelfbraces, these braces must be configurable to generally accommodate avariety of leg geometries irrespective of the particular geometry of aleg.

In recognizing the need for effective knee braces, various knee braceshave been introduced into the marketplace. Such knee braces, however,have generally comprised relatively heavy, bulky apparatuses that failto provide ventilation and evenly distribute pressure from the brace onthe leg of the wearer. Moreover, many contemporary braces are deficientin that the braces are constructed in a manner that do not consistentlyprovide or lack adjustment features for forming a firm, comfortable andsecure interface between the leg and knee of the wearer and the brace.As a result of these drawbacks, many knee braces detract from the user'sendeavor.

The features of the present invention are provided in recognition of theneed for orthopedic braces and components for use therewith that areadjustable in both custom-fit and off-the-shelf braces so as to achievesuperior functional performance characteristics while being comfortableto the wearer when worn. This recognition is realized with the inventiondescribed hereinafter.

SUMMARY

This disclosure describes an orthopedic brace and components for usetherewith. In an exemplary embodiment of an orthopedic brace andcomponents for use therewith, an orthopedic brace includes a rigid frameassembly having rigid frame supports connected by joints. The brace alsoincludes a strap which extends between sides of the frame assembly. Anorthopedic component in the form of a resilient subshell is connected toand extending flexibly outwardly from the frame assembly. The subshellhas a main body and a perimeter edge portion secured along the peripheryof the main body wherein the perimeter edge portion is formed from amaterial having less hardness than a material used to form the mainbody. The strap is connected to at least one end portion of thesubshell.

In another exemplary embodiment, an orthopedic brace in the form of aknee brace includes a rigid frame defining lateral and medial sides, anda frame including proximal and distal frame assemblies having rigidframe supports connected by lateral and medial joints. A proximal strapextends between lateral and medial sides of the proximal frame assembly.An orthotic component such as a resilient proximal subshell is connectedto and extends flexibly outwardly from the proximal frame assembly. Theproximal subshell has a main body and a perimeter edge portion securedalong the periphery of the main body. The perimeter edge portion isformed from a material having less hardness than a material used to formthe main body. The lateral and medial ends of the proximal strap may bedirectly connected to lateral and medial end portions of the proximalsubshell.

The brace may also include a distal subshell connected to and extendingflexibly outwardly from the distal frame assembly. The distal subshelldefines upper lateral and medial end portions extending arcuately fromthe distal frame assembly. An upper distal strap has lateral and medialends directly connected to the upper lateral and medial end portions,respectively, thereby connecting to lateral and medial sides of thedistal frame assembly. The distal subshell may form a concave arcuatecrest located along an upper central section between the lateral andmedial end portions thereof.

The distal subshell may define lower lateral and medial end portionsspaced by a lower central section and extends from a lower centralportion of the distal subshell. The lower central portion may be securedto a lower distal central support of the distal frame assembly, and thelower lateral and medial end portions extend flexibly outwardly from thelower distal central support. The upper lateral and medial end portionsare spaced by lateral and medial clearances, respectively, from thelower lateral and medial end portions.

A lower distal strap having lateral and medial ends may be directlyconnected to the lower lateral and medial end portions, respectively,thereby connecting to the lateral and medial sides of the distal frameassembly. The lower central section is anchored to the lower distalcentral support, and the distal frame assembly includes distal lateraland medial supports upon which the lateral and medial end portions ofthe distal subshell are adjustably secured. The distal subshell has amain body and a perimeter edge portion secured along the periphery ofthe main body. The perimeter edge portion is preferably formed from amaterial softer than a material used to form the main body.

The features described herein in connection with the exemplaryembodiments enable significant improvements to orthopedic devices, suchas knee braces, in the way of improved stability, fit, weight, comfortand appearance. The subshells allow for a considerable reduction inweight and provide close compliance to the anatomy of the wearer. Thisresults in a comfortable device that is particularly less bulky andeasily ventilated and further allowing for better suspension on the leganatomy. These advantageous features combine to form a streamlineddevice allowing the wearer greater freedom, flexibility and stability ofthe anatomy when the device is worn. For example, the construction ofthese features allows for a device in which straps may be mounted underframe elements for better soft tissue containment and a more intimatefit. Further, the subshells have an appearance in combination with anoverall streamlined set of features, which make the device more enticingto wear over prior art braces so as to better assure patient compliancein wearing the brace.

These and other features, aspects, and advantages of the presentinvention will become better understood with regard to the followingdescription, appended claims, and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of an orthopedic brace.

FIG. 2 is a front elevational view of the brace according to FIG. 1.

FIG. 3 is a rear elevational view of the brace according to FIG. 1.

FIG. 4 is a plan view of an embodiment of a subshell used in theorthopedic brace of FIG. 1.

FIG. 5 is a cross-section view taken along line V-V in FIG. 4.

FIG. 6 is a perspective view of another embodiment of an orthopedicbrace.

FIG. 7 is a front elevational view of the brace according to FIG. 6.

FIG. 8 is a rear elevational view of the brace according to FIG. 6.

FIG. 9 is a plan view of an embodiment of a subshell used in theorthopedic brace of FIG. 6.

FIG. 10 is a perspective view of a variation of the subshell of FIG. 9.

FIG. 11 is a perspective view of another variation of the subshell ofFIG. 9.

FIG. 12 is a perspective view of another embodiment of a shell employingcertain features of FIG. 11.

FIG. 13 is a top plan view of an embodiment of a strap retainer.

FIG. 14 is a bottom plan view of an embodiment of the strap retainer ofFIG. 13.

FIG. 15 is front perspective view of the strap retainer of FIG. 13 witha peripheral edge portion.

FIG. 16 is a rear perspective view of the strap retainer of FIG. 13.

FIG. 17 is a perspective view of a strap pad for use with the strapretainer of FIG. 13.

FIGS. 18 and 19 are schematic views of a fastener retainer in the frameof the orthopedic brace of FIG. 1.

FIG. 20 is an elevational view of an embodiment of a fastener retainer.

FIG. 21 is a front elevational view of a patella protector assembly inan extended configuration for use on the brace of FIG. 6.

FIG. 22 is a rear elevational view of the patella protector assembly inFIG. 21.

FIG. 23 is an exploded assembly perspective view of the patellaprotector assembly of FIG. 21.

FIG. 24 is a rear elevational view of a buttress depicted in FIG. 23.

FIG. 25 is a schematic view of the patella protector assembly of FIG. 21on the brace of FIG. 6 when a leg is in extension.

FIG. 26 is a schematic view of the patella protector assembly of FIG. 21on the brace of FIG. 6 when a leg is in flexion.

DESCRIPTION OF VARIOUS EMBODIMENTS A. Overview

A better understanding of different embodiments of the invention may behad from the following description read in conjunction with theaccompanying drawings in which like reference characters refer to likeelements.

While the disclosure is susceptible to various modifications andalternative constructions, certain illustrative embodiments are shown inthe drawings and are described below in detail. It should be understood,however, that there is no intention to limit the disclosure to thespecific embodiments disclosed, but on the contrary, the intention is tocover all modifications, alternative constructions, combinations, andequivalents falling within the spirit and scope of the disclosure.

It will be understood that, unless a term is expressly defined in thispatent to possess a described meaning, there is no intent to limit themeaning of such term, either expressly or indirectly, beyond its plainor ordinary meaning.

Any element in a claim that does not explicitly state “means for”performing a specified function, or “step for” performing a specificfunction, is not to be interpreted as a “means” or “step” clause asspecified in 35 U.S.C. §112, paragraph 6.

B. Environment and Context of Embodiments

Numerous orthopedic brace embodiments and components (e.g., subshellsand strap retainers) for use therewith are described herein, withparticular focus given to braces and components directed to the kneejoint and surrounding areas. The orthopedic brace embodiments may servein protective, preventative or remedial capacities. While the orthopedicbrace is described within the context of a preferred embodiment that isdirected to securing the knee joint, many of the features describedherein may be extended to orthopedic braces and components that secureother joints and body parts, such as the wrist, elbow, shoulder, ankleand neck.

The brace embodiments and components for use therewith may bedimensioned to accommodate different types, shapes and sizes of humanjoints and appendages. In addition, embodiments may be modified toorient principal forces exerted by strap systems of the embodiments atany desirable location to secure the brace onto a leg in order tostabilize the knee.

The knee joint comprises two joints, lateral and medial, between thefemur and tibia, and one arthrodial joint between the patella and femur.The primary movements of the knee comprise flexion, i.e., rearwardrotational movement of the tibia relative to the femur, and extension,i.e., forward rotational movement of the tibia relative to the femur.

For explanatory purposes, each orthopedic brace embodiment or componentthereof described herein may be divided into sections which are denotedby general anatomical terms for the human body. Such anatomical termsare provided to distinguish various elements of the brace embodimentsfrom one another, but which are not to be considered to limit the scopeof the invention.

Each of these terms is used in reference to a human leg, by way ofexample, which is divided in similar sections with a proximal-distalplane generally extending along the meniscus of the knee between thefemur and tibia. The terms “proximal” and “distal” generally refer tolocations of the brace that correspond to the location of leg relativeto the point of attachment of the leg to the body. The terms “upper” and“lower” may be used in combination with “proximal” and “distal” toconnote gradations in-location of “proximal” and “distal.” The locationat where the brace corresponds to the knee joint is used herein togenerally delimit the proximal and distal sections of the brace.

The embodiments of the knee brace can also be considered to fall within“anterior” and “posterior” sections by an anterior-posterior plane. Theanterior-posterior plane generally corresponds to the coronal or frontalplane of a human leg which lies along the central longitudinal axis of abody. A posterior side or element is therefore located behind thisanterior-posterior plane, whereas an anterior side or element is locatedin front of the anterior-posterior plane.

The terms “inwardly” or “inner” commonly used herein to distinguish theside of the brace that may be directed to the posterior side of thebrace and specifically adjacent to the leg of the wearer of the brace.Contrariwise, the term “outwardly” or “outer” are used to denote theside of the brace that is opposite to the inwardly side.

The terms “medial” and “lateral” are relative terms that are generallyunderstood as indicating location near the midsaggital plane or midline.Therefore, elements that are located near the midline are referred to as“medial” and those elements that are further from the midline areconsidered to be “lateral.” The term “central” is used to denote thearea along the midline of a joint thereby dividing and sharing regionsof the medial and lateral regions.

From these terms, it follows that the anterior section of the brace hasthe following quadrants: (I) proximal-medial, (II) distal-medial, (III)distal-lateral, and (IV) proximal-lateral. The posterior section of thebrace has the following quadrants: (V) proximal-medial, (VI)distal-medial, (VII) distal-lateral, and (VIII) proximal-lateral.Structural members and features thereof will fall within one of thequadrants is specifically referenced in relation to such quadrant,either in its entirety or partially.

The terms “rigid” and “flexible” are repeatedly used herein todistinguish characteristics of portions of the brace. The term “rigid”is intended to denote that the frame is generally devoid of flexibility.Within the context of frame members that are “rigid,” it is intended toindicate that they may break if bent with sufficient force. On the otherhand, the term “flexible” is intended to denote that features arecapable of repeated bending. The term “resilient” is used to qualifysuch flexible features as generally returning to the initially moldedshape with permanent deformation.

The anatomical and characteristic terms described herein are notintended to detract from the normal understanding of such terms asreadily understood by one of ordinary skill in the art of orthotics.Moreover, the elements of the embodiments described herein are intendedto embrace embodiments that generally correspond to the aforementionedanatomical sections. In other words, it is understood that the elementsof the brace embodiments described herein may deviate from fallingexactly within the confines of the aforementioned anatomical sections.

C. Various Embodiments of the Orthopedic Brace and Components for UseTherewith

In observing FIGS. 1-3, an embodiment of the orthopedic brace is shownand generally designated 10. For explanation purposes, the orthopedicbrace 10 is a knee brace configured for securing to a right leg of auser. Nonetheless, it is readily apparent to the skilled artisan fromthe discussion herein that the orthopedic brace and particular featuresthereof of the present invention may be adapted to be secured to a leftleg or other parts of the body to treat skeletal joints apart from theknee.

The orthopedic brace 10 comprises a substantially rigid frame 12including proximal and distal frame assemblies 14, 16, a substantiallyflexible distal subshell 46, lateral and medial central joints 18, 20,substantially flexible strap retainers 68, 70, 72, 78, padding, and aplurality of straps. For simplification, the brace embodiments shownherein are depicted without their specific straps and padding. A moredetailed description of possible configurations of the straps and thepadding that may be used in accordance with the orthopedic bracedescribed herein is provided in U.S. patent application publications2006/0135900 and 2007/0185425, owned by the assignee of this disclosureand incorporated herein by reference.

The frame 12 includes a proximal frame assembly 14, a distal frameassembly 16, and lateral and medial joints 18, 20. The proximal frameassembly 14 comprises in combination a lower proximal-laterallongitudinal support 22, lower proximal-medial longitudinal support 24,proximal-central support 26, proximal-central stem 28, and upperproximal-lateral support 30. The distal frame assembly 16 comprises incombination an upper distal-lateral support 34, upper distal-medialsupport 36, distal-central support 38, distal-central stem 40, and lowerdistal-lateral support 42.

The proximal and distal frame assemblies 14, 16 preferably have arcuateconfigurations which are arranged to accommodate the contours of a leg.For example, the upper proximal-lateral support 30 and the lowerdistal-lateral support 42 each include cuff sections 32, 44,respectively, that are intended to conform to lateral aspects of theproximal and distal portions of the leg when the brace is placed on theleg of the user. According to the embodiment of FIGS. 1-3, the proximaland distal frame assemblies do not yield to the contours of the leg butinstead are preformed to a particular shape that accommodates the leg.When worn, the proximal and distal frame assemblies 14, 16 are intendedto be shaped so as to closely trace and secure to the leg.

The proximal and distal frame assemblies 14, 16 are each preferablyconstructed from a unitary or continuous rigid piece of material. Inother words, by way of example in reference to the proximal frameassembly 14, the lower proximal-lateral longitudinal support 22, lowerproximal-medial longitudinal support 24, proximal-central support 26,proximal-central stem 28, and upper proximal-lateral support 30continuously merge into one another. The distal frame assembly 14 issimilarly configured to the proximal frame assembly 16.

The frame 12 is preferably characterized herein as being substantiallyrigid. The rigidity of the frame is generally the result of both thematerial from which the frame is constructed and its geometry. Thematerial and geometry of the proximal and distal frame assemblies 14, 16are generally rigid along the entirety of their length such thatrigidity of the frame assemblies has a generally high and uniformrigidity. Exemplary materials that may be used for constructing theframe include metals such as aluminum, titanium, and steel, thermosetresin composite systems including glass or carbon fibers, andthermoplastics that have been rendered rigid by way of materialcomposition and geometry of the frame members.

It will be noted that the requirement that the frame 12 hassubstantially rigid properties is provided only as an exemplaryconfiguration. It will be noted that the frame may have flexibleproperties, and may further be provided in discrete segments such thatthe proximal and distal frame assemblies are segmented as opposed tocontinuous, and may be connected to one another by suitable hinges,fasteners or other suitable elements.

The proximal and distal frame assemblies 14, 16 are connected to oneanother by the lateral and medial joints 18, 20. The lateral joint 18connects the lower proximal-lateral longitudinal support 22 to the lowerdistal-lateral longitudinal support 34, and similarly the medial joint20 connects the lower proximal-medial longitudinal support 24 and theupper medial-upper longitudinal support 36. The ends of the longitudinalsupports 22, 24, 34, 36 are configured to cooperatively engage thelateral and medial joints 18, 20.

The lateral and medial joints 18, 20 are preferably rotational hinges,which rotationally connect the proximal frame assembly 14 to the distalframe assembly 16. The lateral and medial joints 18, 20 enablerotational displacement of the proximal-lower lateral and mediallongitudinal supports 22, 24 between positions of extension and flexion.Suitable condoyle pads 58 may be used to cover at least portions of thelateral and medial central joints 18, 20, and may be configured to beremovable and replaceable.

The substantially flexible distal subshell 46 secures to a posteriorsurface of the frame 12. The distal subshell 46 connects to thedistal-central support 38 and the distal-central stem 40 via fastenersthrough apertures 92. The distal subshell 46 projects and depends freelyfrom the frame 12 so as to extend into the medial side of the brace andbe located lower from the distal medial longitudinal support 36. Ineffect, the distal medial subshell 46 is a counterpart to the laterallower support 42; however it is significantly flexible, resilient anddurable.

These features and those described that follow, are not limited to a“distal” subshell, but may be extended to a subshell located at anylocation in an orthopedic device. In other words, any of the subshellsdescribed herein are not limited in structure and location with regardto their exemplary embodiments; they may be modified and located at anysuitable location in an orthopedic device.

According to the embodiment of FIGS. 1-3, the distal subshell 46 isdefined, at least in part, by a main body 48. The main body 48 includesa central end region 52 that secures to the distal-central support 38and the distal-central stem 40, a medial end region 56, and anintermediate section 54 that connects the central end region 52 to themedial end region 56. As depicted in FIGS. 2-3, the intermediate portion54 may be narrower than the central and medial end regions 52, 56. Themedial end region 56 is generally enlarged so as to conform to themedial aspect of the lower portion of the user's leg when the orthopedicbrace is placed upon the leg of the user. A significant advantage to thesubshell is that it can be sized to cover a broad portion of the anatomyof the leg to more effectively and comfortably secure (by distributingforces) the brace to the leg without appreciably adding to the weight ofthe brace.

The distal subshell 46 has a ventilation feature 53 in the form ofelongate slots that may extend or be located anywhere on the main body48 and be arranged in a configuration which facilitates the passage ofair through the subshell 46. At least one of the slots 53 defines astrap slot 51 that may be used to secure a strap 66 thereto thatconnects to a corresponding side of the lower distal-lateral support.

The distal subshell 46 may be used in combination with an apertured orventilated padding that may be shaped to accommodate the subshell, orhave any other suitable configuration defining a padding feature. Whilea preferred type of padding is described by way of the spacer elementsin U.S. patent application publications 2006/0135900 and 2007/0185425,other padding can be used that may or may not be ventilated.

In the embodiment of FIGS. 1-3, the subshell 46 is substantially moreflexible than the substantially rigid frame 12. For example, while therigid frame 12 does not yield to the leg when worn, the subshell 46 isflexible so as to bend so as to conform to the leg thereby improvingcomfort to the wearer and further distributing forces exerted onto theleg.

A distinguishing feature of the subshell 46 is that it includes apressure-relieving perimeter edge portion 50. The pressure-relievingperimeter edge portion 50 is distinguished from the main body 46 in thatit preferably has a softer texture. More specifically, the perimeteredge portion 50 has a hardness that is lower than the hardness of themain body 46.

According to one variation, the main body 46 and the perimeter edgeportion 50 are formed from materials having different hardnesses. Inthis variation, the main body 46 and the perimeter edge portion 50 areinjection molded thermoplastics that are integrally molded together. Anexemplary combination of materials comprises thermoplastic polyurethaneelastomers sold under the name ELASTOLLAN by BASF group.

In making the subshell of this variation, the main body is firstfabricated by being formed by a first mold. A first material, such asELASTOLLAN S60D53N, is injected into the mold so as to result in theformation of the main body. The molded main body is then transferred toanother, larger second mold which forms the shape of the definitivesubshell including the perimeter edge portion. The main body is securedand centered in the second mold. A second material, such as ELASTOLLANC60A10W, is injected into the second mold so as to contact the main bodyand form the perimeter edge portion therearound. Due to the similarityin composition of the first and second materials, the second material ofthe perimeter edge portion bonds to the first material of the main bodyas it is formed in the second mold. In this variation, the firstmaterial has a hardness that is greater than the second material.

A significant advantage to this variation of the subshell is that thecombination of a flexible subshell with or without a soft perimeter edgeportion provides a substantially comfortable feature to the orthopedicbrace. Unlike conventional braces, the distal subshell yields to theshape of the leg while retaining the strap and the perimeter edgeportions relieves pressure along the edges of the subshell. This allowsfor better soft tissue containment and an intimate fit thereby providingthe wearer enhanced freedom and flexibility when wearing a device havingthe subshells. This also leads to better suspension of the device havingthe subshell on wearer's anatomy, which assists in maintaining thedevice in the position to optimize bracing. Added with the ventilationfeature, for example the type described in U.S. patent applicationpublication 2006/0135900, the orthopedic brace provides a feature thatreduces bulk weight and size of known subshells or braces in general,and facilitates breathability of the brace.

Another advantage to this variation of the subshell results ineliminating the need to configure the subshell in a manner that wouldinclude portions for receiving the perimeter edge portion. As such, themain body may be molded with a perimeter edge portion that does notinclude ledges, slots or grooves for receiving the subsequently moldedsecond material forming the definitive perimeter edge portion. Thisprovides a generally continuous structure without gaps, raised areas,sharp edges and other protuberances or recesses that may causediscomfort to the wearer of the brace.

Another advantage to this variation of the subshell is that the subshelland the perimeter edge portion, being continuous with the main body, maybe pigmented in a different color from the main body. This provides anappearance resulting in a piping around the periphery of the subshellwhich conveys a visually pleasing appearance. For example, the firstmaterial used for forming the main body of the subshell may have a blackpigment, whereas the second material used for forming the perimeter edgeportion may have a gray pigment.

The appearance of the subshells may be important, in additional to theirbeneficial functional characteristics, in that they may make the bracemore enticing to wear so as to assure better patient compliance of anorthopedic device having the subshells. As readily apparent from thedescription on the structure of the subshells, they allow for morestreamlined orthopedic devices due to their thin profile and theirability to sufficiently conform to the anatomy of the wearer whileassisting to provide superior suspension of the device on the wearer.Moreover, the ornamental appearance, made possible in part by the pipingand the slots, make it more desirable for the wearer to wear the deviceover orthopedic devices having less than desirable aesthetic qualities.This in turns provides the medical professional more assurance that thewearer will more fully comply with the treatment prescriptions orrequirements the device is intended to treat.

Yet another advantage to this variation of the subshell is that thestrap slots may also include a perimeter edge portion that is formedfrom a material that is substantially harder than the material of themain body. Such a material, as with the first and second materials ofthis variation, may again be of a similar nature to the first and secondmaterials, but of a composition that has a greater hardness, so as tocontinuously bond with the subshell and to form an integral subshellstructure. This harder material surrounding a main body is particularlyuseful to provide enhanced durability (i.e., when a strap is arranged torub against the harder material).

It will be noted that it is preferable that the material of the mainbody of the subshell has a toughness that can permit a strap to besecured directly therewith. Such a feature therefore allows the subshellto not only serve as a bracing feature for the orthopedic brace, butalso eliminates the need for additional strap retainers to be secured tothe subshell.

While similar materials are described in connection with this variation,it will be noted that dissimilar materials may also be used. Forexample, polyethylene, polyurethane and other thermoplastics may be usedfor forming the main body, and suitable materials such as vinyl, rubberor thermoplastic elastomers may be used for forming the perimeter edgeportion. Other methods for forming the main body with the perimeter edgeportion may be found in U.S. Pat. Nos. 5,445,602 and 5,716,335,incorporated herein by reference. Moreover, a soft flexible perimeteredge portion may be mechanically adhered, such as an adhesive, to asubshell having ledge, slotted or groove portions upon which theperimeter edge portion may be adhered that does not interlock with anystructure of the main body of the subshell.

It will be pointed out that the perimeter edge portion is merely anexemplary form of overmolding over a main body or base shell. Indeed,the main body or base shell may include other areas of overmolding, suchas a center portion filling in an opening in the base shell, to providepressure relieving characteristics to a shell. In another example, thematerial surrounding and forming slots defining a ventilation feature ofthe subshells may comprise an overmolded material that has differentproperties than a main body or base shell. Such properties may notnecessarily comprise those having less hardness than the main body orbase portion; for example, such properties may be those having a greaterresiliency and hardness than the main body or base portion.

The strap retainers 68, 70, 72, 74, 76, 78, are formed substantially asthe distal subshell 46 in that the strap retainers, by way of strapretainer 68, are substantially flexible and are particularly mounted viaa fastener that extends through fastening aperture 90 of the strapretainer and secures to the inwardly facing side of the frame 12. Thestrap retainer 68 also includes a main body 80 formed from a firstmaterial that has a greater hardness than a perimeter edge portion 82.The strap retainer 68 also includes a strap slot 84, and at least oneventilation feature 86 by way of a slot. The materials used for formingthe strap retainer 68, according to one variation, may be the samematerials used to form the exemplary distal subshell 46 (i.e., the firstmaterial for the main body 80, and the second material for the perimeteredge portion 82).

Like the distal subshell 46, the strap retainer 68 is configured to bendor conform to the contours of the leg of a wearer of the orthopedicbrace. Since the materials of the strap retainer are flexible, andfurther because the strap retainer has a ventilation feature, the strapretainer may be sized larger than conventional D-rings or other strapretainers in orthopedic braces. This allows for the strap retainer todistribute pressure on the leg of the wearer of the brace over a greaterarea than in conventional devices.

In addition to the pressure-relieving flexible perimeter edge portion,the strap retainer has a thin profile. The thin profile is partlyattributed to the ability to size the strap retainer larger thanconventional attachment devices due to the ventilation feature and thelightweight nature of the materials used to form the strap retainer. Thestrap retainer may therefore be secured on the inwardly facing side ofthe frame 12 which is an advantage over conventional attachment devicessince mounting such devices on the inwardly facing side of the frame ofa brace would likely cause discomfort to the leg of the wearer becausethese devices tend to be substantially rigid and bulky. The thin profileof the strap retainer is also beneficial in that it may be used with apad, as depicted in FIG. 13, to provide an additional comfort aspectthat relieves pressure.

In a variation of the distal subshell depicted in FIGS. 1-3, FIG. 4illustrates a distal subshell 93 having a main body 94 and a perimeteredge portion 95. Unlike the distal subshell 46, this variation has abeveled perimeter edge portion 97 which corresponds to the tibia portionof the wearer. Because the tibia is prone to sensitivity, this beveledportion 97 allows for greater cushioning from its transitional profileand the soft nature of the material used to form the perimeter edgeportion.

The distal subshell 93 also includes apertures 97 whereat a harder andtougher material may be used in a surrounding portion 98 about theaperture 97. This provides for greater durability when the material ofthe main body 94 may not be sufficiently strong to withstand repeatedmovement or tensioning of the subshell about a leg. The surroundingportion 98 may be molded over the main body 94 in accordance with any ofthe methods described herein.

FIG. 5 illustrates a cross-sectional view taken along line V-V in FIG.4. This cross-sectional view exemplifies how the main body 94 may beformed with a ledge or similar feature 99 upon which the material of theperimeter edge portion 97 is molded onto and bonds with the material ofthe main body 94. The ledge 99 is not limited to the configuration asshown herein but may comprise a spline, slots (through which materialmolded thereover interlocks), or other suitable arrangements whichassure a secure interlocking of material of the perimeter edge portionand the main body.

In another orthopedic brace embodiment 100 illustrated in FIGS. 6-8, thebrace 100 may have a configuration wherein the proximal and distalsubshells replace certain supports and strap retainers described incombination with the orthopedic brace 10 of FIGS. 1-3.

The frame 102 includes a proximal frame assembly 104, a distal frameassembly 106, lateral joint 108, and medial joint 110. The proximalframe assembly 104 is substantially rigid, as in the frame assembly 14of the brace embodiment 10, and comprises in combination aproximal-lateral longitudinal support 112, proximal-medial longitudinalsupport 114, lower proximal-central support 116, and upperproximal-central support 118. The distal frame assembly 106 comprises incombination a distal-lateral support 120, distal-medial support 122,upper distal-central support 124, and lower distal-central support 126.The lateral and medial central joints 108, 110 operate in a similarmanner to those described in connection with the embodiment of FIGS.1-3.

Similar to the brace embodiment 10, the proximal and distal frameassemblies 104, 106 preferably have arcuate configurations which arearranged to accommodate the contours of a leg. As with the frame 12 ofthe orthopedic brace 10, the frame 102 is preferably characterizedherein as being substantially rigid. Moreover, the proximal and distalframe assemblies do not yield to the contours of the leg but instead arepreformed to a particular shape that accommodates the leg. When worn,the proximal and distal frame assemblies are intended to be shaped so asto closely secure to the leg.

The proximal and distal frame assemblies 104, 106 are also eachpreferably constructed from a unitary or continuous rigid piece ofmaterial. The upper proximal-central support 118, and the lowerdistal-central support 126, each gradually taper as they extend awayfrom the lower proximal-central support 116, and the upperdistal-central support 124, respectively. Preferably, as shown in FIGS.6-8, the upper proximal-central support 118, and the lowerdistal-central support 126 have arcuate profiles so as to mitigate anysharp geometry that may pose uncomfortable to the wearer of the brace,and to ease the pressure exerted onto the femur and tibia, respectivelywhile providing support to such areas of the leg.

As with the brace 10 of FIGS. 1-3, the brace 100 includes lateral andmedial strap retainers 186, 188 that are pivotally secured viaconnection points 190 to the proximal lateral and medial longitudinalsupports 112, 114. The strap retainers 186, 188 may have the sameconfiguration as the strap retainers described in connection with thestrap retainers of brace 10.

The brace 100 includes a proximal subshell 128 that is secured to theinwardly facing side of the frame 102 at the lower and upperproximal-central supports 116, 118. The proximal subshell 128 includeslateral and medial sections 137, 138 that generally extend from a centerportion 142 that is secured to the lower and upper proximal-centralsupports 116, 118. The lateral and medial sections 137, 138 each includean intermediate portion 141 that connects the center portion 142 toenlarged lateral and medial end portions 143, 145, respectively.

The lateral and medial end portions 143, 145 are preferably sized largerthan the intermediate portion 141 so as to embrace a greater portion ofthe lateral and medial aspects of the leg. The lateral and medial endportions 143, 145 each include at least one strap slot 134 for securinga strap 176 that extends between lateral and medial end portions on theinwardly facing side of the brace 100. The at least one strap slot 134on both the lateral and medial end portions 143, 145 effectivelyreplaces the need for any strap retainer. Due to the enlarged size ofthe lateral and medial end portions 143, 145 in combination with thestrap 176, the pressure exerted onto a leg when the corresponding strapis tightened is able to be distributed over a larger area than is foundin conventional braces.

As with the subshell 46 of the brace 10, the proximal subshell 128includes a main body 130 and a peripheral edge portion 132. While themain body 130 is preferably flexible, the peripheral edge portion 132 issubstantially flexible and has a hardness that is less than a hardnessof the main body. The proximal subshell 128 may be constructed in asimilar manner as the subshell 46 of the brace embodiment 10 of FIGS.1-3.

Moreover, both the main body 130 and the peripheral edge portion 132 ofthe proximal subshell 128 may extend beyond the periphery of the lowerand upper proximal-central portions 116, 118 so as to minimize orrelieve any pressure exerted on the leg of a wearer due to the rigidityof the lower and upper proximal-central portions 116, 118.

The proximal subshell 128 includes a ventilation feature 136 that isexemplified by a plurality of slots. While other configurations may beused in addition to the slots 136, this particular configuration ofFIGS. 6-8 allows for at least some of the slots to be sized andconfigured to also receive the strap 176 in addition to the strap slot134 to provide greater size adjustment to the strap or allow for thestrap to extend over a greater portion of the subshell. The slots 136,or other ventilation structure, may be used in combination with atextile or foam pad, or a ventilated spacer element of the typedescribed in U.S. patent application publication 2006/0135900 and2007/0185425. The combination of the ventilation feature with aventilated spacer element enables the brace to be tailored so as toprovide air passage through the subshell to allow for a substantiallybreathable portion of the brace.

While not shown, the proximal subshell may be mechanically secured tothe frame 102 by suitable fasteners or adhesives. In a variation, theproximal subshell may be provided with different apertures or slotswhich enable the subshell to be adjustable relative to the upper frameassembly 104. Certain adjustability may be related to the height of thesubshell, varus and valgus adjustment, and the ability to move freely upand down relative to the upper frame assembly when the brace is worn.Various means for providing adjustability for the proximal subshell 128may be similar to those used in adjusting a distal or tibial subshell144 to the distal frame assembly 106 described hereafter.

The distal subshell 144 is secured to the inwardly facing side of theframe 102 at the upper and lower distal-central supports 124, 126. Theproximal subshell 144 includes lower lateral and medial sections 154,162 that generally extend from a lower central portion 158 that isimmovably secured or anchored to the lower distal-central support 126 byat least one fastener 159. The lower lateral and medial sections 162,154 each include a lower intermediate portion 157, 156, respectively. Aswith the lateral and medial end portions 137, 138 of the proximalsubshell 128, the lower lateral and medial sections 162, 154 each haveenlarged geometry relative to the intermediate portions 157, 156 so asto embrace a greater portion of the lateral and medial aspects of theleg.

The lower lateral and medial sections 162, 154 each include at least onelower strap slot 150 for securing a strap 182 that extends between thelower lateral and medial sections on the posterior side of the brace100. The lower lateral and medial sections 162, 154 include aventilation feature 152 by way of a plurality of slots similar to thoseof the proximal subshell 128.

The distal subshell 144 also comprises an upper central portion 160 thatextends proximally from the lower central portion 158, and includes aconcave arcuate crest section 161 that is configured to conform to thetibia of the wearer of the brace 100. Upper lateral and medialintermediate sections 166, 168 connect respectively to upper lateral andmedial sections 164, 170. Both the lateral and medial sections 164, 170include at least one upper strap slot 151, and the ventilation feature152. Moreover, both the upper lateral and medial sections 164, 170 areenlarged relative to the upper intermediate sections 166, 168.

Both the upper lateral and medial sections 164, 170 include at least oneupper strap slot 151 that connects the upper lateral and medial sectionsvia a strap 180. The upper lateral and medial sections 164, 170effectively serve as both a support for the wearer of the brace and asstrap retainers.

The upper lateral and medial sections 164, 170 are adjustable relativeto the lower frame assembly 106, and in particular to the distal-lateralsupport 120, and distal-medial support 122. FIGS. 6 and 8 illustrate theupper lateral and medial sections that each define a slot 172 throughwhich a corresponding tightenable fastener 174 extends and secures tothe distal-lateral support 120, and distal-medial support 122,respectively.

In a variation, FIG. 9 shows a plurality of adjustment apertures 208which are spaced in a manner that incrementally allows for adjustment ofthe upper lateral and medial sections 164, 170 relative to the distallateral and medial supports 120, 122. Such adjustment of the upperlateral and medial sections enable the adjustment of the alignment ofthe distal subshell and may contribute to an anterior or posterior forceon the tibia. The flexible nature of the subshell allows for complianceto the leg anatomy throughout the range of adjustment.

As with the proximal subshell 128, the distal subshell 144 includes amain body 146 and a peripheral edge portion 148. While the main body 146is preferably flexible, the peripheral edge portion 148 is substantiallyflexible and has a hardness that is less than a hardness of the mainbody. The proximal subshell 144 may be constructed in a similar manneras the subshell 46 of the brace embodiment 10 of FIGS. 1-3.

Both the main body 146 and the peripheral edge portion 148 of the distalsubshell 144 may extend beyond the periphery of the upper and lowerdistal-central portions 124, 126 so as to minimize or relieve anypressure exerted on the leg of a wearer due to the rigidity of the upperand lower distal-central portions 124, 126.

FIG. 9 shows a variation of a distal subshell 200 that may replace thedistal subshell 144 in the brace 100. The distal subshell 200 includes aplurality of differently shaped ventilation features 202, 204, 206 thatcorrespond to different regions of the distal subshell 200. It will beunderstood that the ventilation features may be modified in a pluralityof different configurations and are not limited to those shown ordiscussed herein. Of course, the ventilation features may be arranged soas to optimize or facilitate the passage of air through the subshell andany padding, liner or spacer element located between the leg and thesubshell.

The distal subshell 200 also includes apertures 210 surrounded byrecesses 212 for receiving fasteners that are used for securing thedistal subshell 200 to the lower distal-central portion 126 of the brace100. It will be pointed out that there are preferably, while not limitedthereto, apertures and recesses for receiving fasteners defined on thedistal subshell 200 that correspond to the upper distal-central portion124. This is so the upper lateral and medial sections 164, 170 may beadjusted relative to the distal lateral and medial supports 120, 122,respectively, via the plurality of adjustment apertures 208.

FIG. 10 illustrates a variation of an orthotic or subshell 230 having amain body 146 configuration similar to the distal subshell 200. Thedistal subshell 230 includes a peripheral edge portion 148 that forms alip 232 that extends over one surface of the main body 146. A groove orclearance 234 is defined between the lip 232 and the surface of the mainbody 146 generally about the periphery of the main body 146. While theperipheral edge portion is described as having one lip extending over afirst side of the main body, it will be noted that the peripheral edgeportion may form lips located over opposed sides of the main body,thereby forming clearances between the lips and such surfaces.

The combination of the groove and the lip 232, 234 defines a retainingstructure or pocket for receiving a pad or spacer element having asimilar profile to that of the main body 146. The peripheral edgeportion is preferably formed from a resilient material so that such lipsmay clamp against a pad or spacer similarly shaped to the main body andplaced within the confines of the pocket. This retaining structuretherefore facilitates installation and removal of pads or spacerelements relative to the distal subshell 230.

The lip and groove 232, 234 conceals edges of any pad or spacer elementretained thereby so as to visually hide the pad or spacer element, andfurther protect the edges of the pad or spacer element. This structurealso advantageously makes it so that it is not necessary to use anyfasteners, adhesive or other suitable means to secure pads or spacerelements to the subshell. The retaining structure exemplified in FIG. 10may be extended to any of the subshells described herein.

FIG. 11 depicts yet another variation of an orthopedic component orsubshell 240 which includes features that may be used in any of thesubshells described herein. According to this variation, the subshell240 is divided into individual shell portions 241, 242, 243, 244 whichare connected to one another via a connective portion 245 formed from amaterial similar to the material used to form the perimeter edge portionin other embodiments described herein. The shell portions may be formedfrom a material similar to the material used to form the main body inother embodiments described herein. In other words, the shell portionsare formed from a less compressible and tougher material than theconnective portion.

The connective portion 245, as in the embodiment of FIG. 10, defines alip 246 extending over the periphery of each of the shell portions 241,242, 243, 244. The lip 246 is spaced above the shell portions 241, 242,243, 244, on one side thereof, so as to define a groove or clearance 247therebetween effectively forming a retaining structure or pocket. Aswith the embodiment of FIG. 10, the lip and groove 246, 247 can retainand conceals edges of any pad or spacer element retained thereby so asto visually hide the pad or spacer element, and further protect theedges of the pad or spacer element without the requirement of anyfasteners, adhesive or other suitable means to secure pads or spacerelements to the subshell. It will be pointed out that the composition ofthe connective portion is not restricted to materials having lesshardness, but it may actually have a greater rigidity or hardness thanthe shell portions.

Also depicted in FIG. 11 is a tibial recessed portion 248 which isdefined generally at a location corresponding to the wearer's tibia.This recessed portion 248 comprises only the softer and more resilientmaterial forming the connective portion 248. It follows that thissection has a transitional, beveled section 249 leading to a portion ofdecreased thickness as compared to portions of the subshell having thecombination of the shell portions and connective portion. This recessallows for greater cushioning and compliance about the tibia, similar tothe concept used in accordance with the embodiment of FIG. 4. As withthe retaining structure for a pad or spacer element, the recessedportion is preferably located on a side of the subshell which is locatedadjacent to the leg of the wearer. It will be pointed out that therecessed portion is not restricted to corresponding to the tibia of thewearer, but the concept of the recessed portion may be extended orplaced to any location considered appropriate.

Turning to another embodiment of an orthotic shell employing featuresfound in part by the variations of FIG. 10 and 11, the orthotic shell250 of FIG. 12 exemplifies a shell construction wherein shell bodies252, 254 are connected by connective portion 256. As with theembodiments of FIG. 11, the connective portion 256 forms a lip 257 whichextends over the shell bodies 252, 254 and is spaced over such shellbodies 252, 254 on one side thereof to form a groove or clearance 258.The orthotic shell 250 is particularly in the brace described in U.S.patent application publications 2006/0135900 and 2007/0185425.

The lip 257 extends on one side of the shell 250 so that the clearance258 defines the extension of the lip 257 relative to a central portion260 of the connective portion 256. In other words, the central portion260 is thinner than at the lip 257. It may also be configured thinnerthan the shell bodies since these shell bodies do not directly connectto one another; they are preferably connected only by the connectiveportion 256. The central portion 260 may correspond similarly to thetibial recessed portion 248 in FIG. 11 so as to relieve pressure at aparticular portion of the tibia.

The connective portion 256 may be formed from similar materials as theperimeter edge portion of the embodiment of FIG. 10 or the connectiveportion of the embodiment of FIG. 11. Similarly, the shell portions 252,254 may be formed from similar materials as the shell portions of theembodiment of FIG. 11.

It will be pointed out that while it is explained that the shellportions in FIGS. 11 and 12 do not directly connect to one another, theshells of the embodiments of FIGS. 11 and 12 may be configured so thatshell portions are directly connected to one another or are formedcontinuously with one another. In the event the shell portions werecontinuously formed with one another as a single body portion, thecentral portion or recessed portion may be formed such that the singleshell portion has a reduced thickness in comparison regions outside ofsuch central or corresponding region.

FIGS. 13 and 14 exemplify the main body 306 of an embodiment of a strapretainer 300 prior to receiving a flexible peripheral edge portion ofthe type described in connection with the orthopedic braces 10, 100. Inthis embodiment, the main body 306 defines inwardly and outwardly facingsides 301, 303. The main body 306 includes a head portion 304 definingan aperture 316, a tail portion 306 defining a strap slot 308, and aventilation feature 310, exemplified herein by a slot.

Reinforcement elements 312, 314 are either integrally formed ormechanically adhered to the inwardly facing surface 301 of the main body302 and provided around at least end regions of the strap slot 308 andthe slot 310. The reinforcement elements 312, 314 strengthen sections ofthe strap retainer so as to prevent tearing of the strap retainer and tostiffen the strap retainer at pre-selected sections. While it ispreferred to provide the reinforcement elements only at the end portionsof the strap slot 308 so as to allow the strap retainer to readily flex,other configurations of reinforcement elements may be used such as thosethat extend partially or entirely around any one of the slots or similarstructure of the strap retainers. Moreover, the reinforcement elements,such as element 314, may be provided at regions of the strap retainerthat are meant to bend, as depicted in the configuration of FIGS. 15 and16.

As shown in FIG. 14, the outwardly facing surface 303 does not includereinforcement elements. However, it will be understood thatreinforcement elements may be provided on the outwardly facing surfacein configurations similar to those described in connection with theinwardly facing surface 301.

While the ventilation feature 310 is shown as a slot, the ventilationfeature may assume a variety of configurations that do not significantlyhinder the flexibility and strength of the strap retainer. Someconfigurations include a plurality of apertures, slots, and othersuitable shapes, sizes and combinations thereof. Moreover, theventilation feature need not include corresponding reinforcementelements.

The strap retainer 300 is depicted in FIGS. 15 and 16 with a peripheraledge portion 318 of the type described above in connection with theembodiments of braces 10, 100. The strap retainer 300 also includes afastener guard 320 with flexion features 322 that cover a fastener whenthe strap retainer 300 is secured to a frame of the orthopedic device.

In FIGS. 15 and 16, the strap retainer 300 is formed in a curvedconfiguration which may represent the strap retainer 300 as either in acondition wherein it is molded so as to curve, or so that it representsthe strap retainer 300 when it is flexed about the leg of the wearer dueto the securing of a strap between lateral and medial strap attachments.

The fastener guard 322 serves to protect the leg of the wearer of theorthopedic brace from any hard or sharp edges of the fastener. It alsohas cushioning and flexible properties similar to the peripheral edgeportion 318. The fastener guard 320 allows for the strap retainer 300 tobe mounted on the inwardly facing side of the frame without causingdiscomfort to the wearer of the orthopedic brace. The flexion feature322 permits the fastener to be removed from the strap retainer and framewithout destroying the strap retainer.

The fastener guard 320 may be formed from the same material that is usedas the peripheral edge portion 318, and may be integrated with the mainbody 302 when the peripheral edge portion 318 is molded onto the mainbody. Alternatively, the fastener guard 320 may be formed from the samematerial as the main body 302, or from a different material from theperipheral edge portion 318 and the main body 302. Alternatively, thefastener guard 302 may be mechanically adhered to the main body 302.

While the strap retainer is described and shown herein in a particulargeometry, it will be understood that the strap retainer may beconfigured in a variety of configurations. However, any suchconfigurations must provide means for securing a strap thereto, andmeans for pivotably securing the strap retainer to the frame of a brace.

In observing FIG. 17, a strap pad 350 may be provided that has a shapegenerally corresponding to the shape of the strap retainer 300. Thestrap pad 350 includes a main body 352 corresponding to the main body304, a recessed head 354 that accommodates the fastener guard 320, aslot 358 that accommodates the ventilation feature 310, and a recessedtail 356 that accommodates the strap slot 308. While not shown, thestrap pad 305 may also include recesses or depressions that canaccommodate the reinforcement elements, and perforations by way of itsinherent material composition or mechanical perforations.

The strap pad 350 is secured to the inwardly facing surface 301 of thestrap retainer 300 so as to be proximate to the leg of the wearer of theorthopedic brace. The strap pad 350 may be mechanically adhered to thestrap retainer 300, or removably secured via hook and loop fastenerelements or other suitable elements.

The orthopedic brace may include fastener retainers integrated orsecured within the shell, as depicted in FIGS. 18-20, for securing thestrap retainers, subshells, and straps to the frame. For example, inFIG. 1, the strap 62 may have one end directly secured to the upperproximal-lateral support via a fastener 88 that is received by afastener retainer (not shown).

In accordance with one embodiment, the fastener retainer 408 is pressfitted into the frame 404 from the outwardly facing side so that anorifice 416 of the fastener retainer 408 is exposed on the inwardlyfacing side of the frame 404. A recess 406 may be formed within theframe thickness so as to accommodate the fastener retainer 408, or thefastener retainer 408 may be urged through the frame while the compositematerial cures. Upon curing of the composite material, the outwardlyfacing surface of the frame 404 is treated with a covering material,primer and paint (collectively represented as 402) so as to cover thefastener retainer 408 from the outwardly facing side.

In another embodiment, the fastener retainer 408 is laminated within theframe 404 thereby forming a region 406 wherein the fastener retainer 408is contained. The fastener retainer 408 is effectively embedded withinthe frame 404 with only its orifice 416 being exposed along the inwardlyfacing side of the frame 404.

As shown in detail in FIG. 12, the fastener retainer 408 includes theorifice 416 leading to a threaded portion 414, flanged head 410, and anouter surface 412 including a plurality of cleats 418 extendingtherefrom. The cleats 418 serve to lock the fastener retainer 408 withinthe thickness of the frame 404, and to prevent the fastener retainer 408from loosening from the inwardly facing surface of the frame 404.

The fastener retainer 408 prevents the need for any protuberancesextending from either the inwardly or outwardly facing surfaces. Inother words, any fasteners are preferably maintained in a low profilemanner so as to minimize or avoid any hard areas on the brace that maydiscomfort the wearer, or snag on clothing or other items that the bracemay come into contact with. Moreover, such a low profile alsocontributes to an overall aesthetic appearance that conceals many of thefasteners used to secure the various subshells, straps and strapretainers of the brace.

The fastener retainer may be constructed from a variety of materialssuch as metals and plastics that can withstand repeated securing offasteners. Furthermore, the fastener retainer must be constructed from amaterial that will assure that the cleats remain embedded or securedwith the frame.

In another embodiment in accordance with the invention, the brace mayinclude a patella protector assembly using the concepts described abovein accordance with the embodiments of FIGS. 1-16.

In observing FIGS. 21-23, the orthopedic brace of FIG. 6 is shownincluding an orthopedic component in the form of a patella protectorassembly 500. This assembly 500 includes an upper shell 508 and a lowershell 510 which are slidably and telescopically connected to a centralshell 501 so as to cover the patella of a wearer and to leave no gapbetween any of the three shells 501, 508, 510. The central shell 501 isconnected at the hinge of the brace, whereas the upper and lower shells508, 510 are connected via extension portions 512, 514 or elasticelements (not shown), respectively, to upper and lower frame elements ofthe brace. Thus, as the leg moves, the central shell 501 moves relativeto the upper and lower shells 508, 510 so as to accommodate flexion ofthe leg as the central shell 501 generally remains in place over theknee and hence the patella.

For example, as shown in FIG. 25, the wearer has a knee in an extendedposition wherein the upper shell 508 is partially concealed under thecentral shell 501, and the lower shell 510 is likewise partiallyconcealed under the central shell 501. When the knee is in flexion, asshown in FIG. 26, the upper shell 508 slides away from the central shell501, and the lower shell likewise slides away from the central shell501. In each position, and throughout the range of motion of the knee,the patella protector assembly provides protection of the patella andportions of the leg thereabout while accommodating movement of the kneeand leg.

The connection of the upper and lower shells 508, 510 to the centralshell 501 is generally concealed so as to minimize any parts extendingfrom the patella protector assembly that may break or catch on anything.For example, the connection of the upper and lower shells 508, 510 tothe brace frame elements is provided by way of the extension elements512, 514 which are secured to an inner side of the frame assemblies ofthe brace by suitable fasteners such as rivets or hook and loop systems.These extension elements 512, 514 are generally contoured to accommodatethe shape of corresponding section of the leg. The extension elements512, 514 extend underneath or connect to the interior side of the frameassemblies of the brace so as to hide any fasteners. Likewise, as willbe explained below, the connection of the upper and lower shells to thecentral shell is concealed so as to avoid exposing any connectingelements or fasteners that may be damaged from any impact during use ofthe patella protector assembly.

As depicted in FIGS. 22 and 23, the assembly 500 includes padding liners524, 525, 526 which correspond to the shells 501, 508, 510,respectively. The liners are formed with contours 528 which accommodatethe leg anatomy. The liners may be secured to the shells in accordancewith known fasteners or adhesives, or alternatively the shells may beformed similarly to the embodiments of FIGS. 10-12 which include meansto accommodate liners without the necessity of fasteners or adhesives.The shells and the liners hence are formed to closely follow thecontours of the leg so as to maintain a streamlined and unobtrusiveconfiguration which minimizes interference from apparel and equipmentthat may be used when the brace and assembly are worn together.

The liners may be constructed from open celled foam, such as EVA foam,so as to provide superior shock absorbing properties. The inner surface(surface adjacent the leg anatomy of the wearer) of the liner mayinclude a layer material such as suede, nylon or other material selectedfor comfort and durability. The outer surface of the liner may include alayer of loop material and the inner surface of the shells may includesuitable hook structure for engaging the loop material.

As illustrated in FIGS. 21 and 23, the central shell 501 includes arigid main shell 502 and a more flexible perimeter edge portion 504extending about the periphery of the main shell 502 is secured. Thisconstruction of the main shell 502 and the perimeter edge portion 504 issimilar to that of the subshells in accordance with the embodiment ofFIGS. 1-3 wherein the perimeter edge portion has greater flexibilitythan the top shell.

Unlike the aforementioned subshells in other embodiments describedherein, the main shell is preferably more rigid and tougher than thesubshells, and further the perimeter edge portion may likewise be formedfrom a tougher material that is resilient and not rigid like the mainshell. For example, the main shell may be constructed from a blend ofpolyamide and ABS, such as the commercial product TERBLEND sold by BASF,so as to provide excellent impact strength, high surface quality, easyprocessing, chemical resistance, heat resistance and a pleasant feel. Onthe other hand, as with materials used in the aforementioned subshells,the perimeter edge portion may be constructed from thermoplasticpolyurethane, such as ELASTOLLAN.

The perimeter edge portion 504 preferably extends about the entirety ofthe periphery of the main shell 502 so as to provide a compliant edge,and so as to secure to the brace via a resilient connection. Theresilient connection is preferably defined by opposed wings 516extending laterally relative to the central shell and are arranged forpreferably securing about the hinge of the knee brace. Each wing 516 hasan opening 518 configured for securing about a hinge, thereby permittingthe insertion of the wing 516 between hinge plates of a hinge so as toclamp it to the brace. The opening 518 also may accommodate a condylepad which may be secured to the hinge (as in pad 184 in FIG. 4).

Because the perimeter edge portion 504 is formed from a substantiallyresilient material, it can withstand twisting of the knee and stillsupport the main body relative to the hinges. This is advantageous whenthe brace is used for sports in that the patella protector assembly can,while overall providing resistance and protection, accommodate minormovements or shifting of the knee while still covering the knee. Thisfurther provides comfort to the wearer in that the perimeter edgeportion allows for a more comfortable fitting about the knee while thecentral shell still provides sufficient protection by way of the rigidtop shell.

The upper and lower shells 510, 512 are constructed similarly to thecentral shell 501, in that each of the shells 510, 512, includes a mainbody 511, 513, the extensions 513, 514, respectively, and include aperimeter edge portion 533, 534, respectively. These shells can beformed from the same aforementioned materials used for forming thecentral shell.

The central shell 501 has an arcuate cross-section which is generallycontoured to accommodate the patella portion of the anterior knee. Theupper and lower shells 510, 512 are correspondingly contoured incross-section to generally permit pivoting of at least 90° relative toand from one end connected to the central shell without interference bythe central shell. Moreover, and quite advantageously, the contour ofthe upper and lower shells closely corresponds to the central shell soas to minimize gaps between the shells upon extension and flexion of theknee, and thus movement of the shells relative to one another.

This unique cooperation and configuration among the shells impartssuperior articulation of the shells relative to one another. Thecooperation and configuration allows the assembly to afford protectionof knee while allowing for an ease of movement among the shells andcomfort to the wearer without hindering performance of the wearer inmovement of the knee. Advantageously, the concepts of the patellaprotector assembly may be extended to a variety of suitable otherconfigurations to protect other anatomy other than a knee.

As with the aforementioned subshells, the central shell 501, and theupper and lower shells 510, 512 define a ventilation feature 522, formedby way of a plurality of apertures that are arranged in a predeterminedpattern. The ventilation feature may be used in combination with theliners 524, 525, 526, of the type described above, thereby providing thesame benefits of the aforementioned subshells. The liners may form nubs531 which extend through the apertures of the ventilation feature 522.

The main shell 502 includes a plurality of elongate ribs 520 protrudingoutwardly from a front surface thereof. These ribs 520 may be formedfrom the same material as the main shell 502, or may be formed from adifferent material (having different toughness and impact resistance)and molded directly onto the top shell in areas thereof of increasedthickness. These ribs 520 are advantageous in that they serve toreinforce the main body and deflect impact thereby assisting in theprevention of damaging of the top shell.

The central shell 501 forms elongate slots 535, 536 which extend in thelongitudinal direction thereof. These elongate slots 535, 536 open toboth the front and rear surfaces of the central shell 501, and arearranged to accommodate shell retention elements belonging to the upperand lower shells, as will be discussed below. The slots 535, 536 alsocorrespond to slots 537, 539 formed in the liner 524, as depicted inFIG. 23. Along the front surface, the central shell 501 forms anelongate recess 564 into which the slots 535, 536 open into.

The elongate recess 564 is arranged to accommodate a buttress 506 thatprotrudes outwardly from the front surface of the main shell 502 andgenerally spans the longitudinal length of the main shell 502. Thebuttress 506 is preferably formed from a material that is tougher thanthe main shell 502 so as to provide improved impact resistance at thecenter of the patella protector assembly. Since the material used toform the buttress may have a greater weight, the size and location ofthe buttress may be limited so as to allow for lighter weight materialsto be used for the main body thereby providing a lightweight patellaprotector assembly.

As illustrated in FIG. 24, the buttress 506 defines a plurality of nubs556 which engage notches 538 formed along the recess 564 of the mainshell 502. This allows for the buttress 506 to be separately formed fromthe main shell 502 and inserted into the recess 564. In the alternative,the buttress 506 may be directly molded or inserted into the centralshell 501 whereby by the nubs 556 interlock with the notches 528. Thebuttress 506 also defines a plurality of ribs 558 serving a similarfunction to the ribs 520 formed on the central shell 501. Further, whilethe buttress 506 extends outwardly from the front surface of the topshell, the peripheral edges 554 of the buttress 506 are preferablybeveled so as to minimize sharp edges and provide greater impactresistance.

Each of the upper and lower shells 508, 510, has a shell retentionelement 530, 532. Each shell retention element 530, 532 defines agenerally arcuate neck 542, 548 formed along an end portion proximate tothe central shell. A cross-bar 540, 550 is formed from each of the necks542, 548, respectively.

The cross-bars 540, 550 are formed so as to slidably engage the frontsurface area around the slots 535, 536 of the central shell 501. Thus,the cross-bars 540, 550 have a width greater than the slots 535, 536.The necks 542, 548 thus have a height that is minimally greater than thecombined thickness of the central shell 501 and the liner 524 since thenecks 542, 548 effectively are located within the slots 535, 536, 537,539 so as to permit the cross-bars 540, 550 to engage and slide relativeto the slots 535, 536 and extend into the recess 564.

FIG. 24 shows the back surface of the buttress 506 wherein opposedrecesses 566, 568 are defined and have a width greater than a width ofthe cross-bars 540, 550. Limits 570 are likewise formed to preventsliding of the cross-bars 540, 550 in a first direction (extension ofthe assembly), and limits 571 prevent sliding of the cross-bars 540, 550in second direction (flexion of the assembly). The recesses 566, 568effectively combine with the recess 564 to control sliding of thecross-bars 540, 550.

From the shape of the neck and cross-bars of each shell retentionelement, the upper and lower shells are able to pivotably articulate,via particularly the shape of the arcuate neck, to accommodate movementof the knee as such shells slide relative to one another as the kneegoes between extension and flexion. In other words, the upper and lowershells are able to rotate at the shell retention elements relative tothe central shell. Thus, not only do the shells slide relative to oneanother, rotational movement is permitted which allows the wearer of theassembly to articulate the knee without hindrance while affording thenecessary protection.

It will be pointed out that certain features of the assembly may bereplaced by elastic elements. For example, the shell extensions may bereplaced by or connect to the frame assemblies of a brace via elasticelements. Alternatively, the shell retention elements may be replacedwith elastic elements which connect the upper and lower shells to thecentral shell.

While the foregoing embodiments have been described and shown, it isunderstood that alternatives and modifications of these embodiments,such as those suggested by others, may be made to fall within the scopeof the invention.

1. An orthopedic device, comprising: a rigid frame defining lateral andmedial sides, the frame including a plurality of structural elements; atleast one strap connecting to the lateral and medial sides of the frame;and a resilient subshell connected to and extending flexibly andlaterally outwardly from the frame, the subshell having a main body anda perimeter edge portion secured along the periphery of the main body,the perimeter edge portion being formed from a material having a lowerhardness than a hardness of a material used to form the main body;wherein a first end of the at least one strap is connected to least oneend portion of the subshell.
 2. The orthopedic device according to claim1, wherein the subshell defines at least one slot, the first end of theat least one strap looped about the at least one slot for connecting thefirst end thereof with the subshell.
 3. The orthopedic device accordingto claim 2, wherein the subshell includes a slot edge portion extendingabout at least a portion of the at least one slot, the slot edge portionhaving a greater hardness than the main body, thereby serving as areinforcement to reduce or prevent chafing of the at least one strapagainst the subshell.
 4. The orthopedic device according to claim 1,further comprising a ventilated padding corresponding in shape to the atleast one subshell; wherein the subshell defines a plurality of elongateslots arranged at predetermined locations, the slots corresponding tothe ventilated padding to allow a passage of air through both thesubshell and the padding.
 5. The orthopedic device according to claim 1,wherein the subshell defines at least one elongate slot, the subshellhaving at least one reinforcement element protruding outwardly from thesubshell and located about the at least one slot.
 6. The orthopedicdevice according to claim 1, the subshell having at least one enlargedend portion sized greater than and flaring from a mid-span portion ofthe subshell.
 7. The orthopedic device according to claim 1, wherein theperimeter edge portion defines an end portion having a reduced,transitional thickness and extending beyond the periphery of thesubshell.
 8. The orthopedic device according to claim 1, wherein theperimeter edge portion is directly secured and interlockingly formedalong the peripheral edge of the main body.
 9. A knee brace, comprising:a rigid frame defining lateral and medial sides, the frame includingproximal and distal frame assemblies comprising rigid frame supportsconnected by lateral and medial joints; a proximal strap extendingbetween lateral and medial sides of the proximal frame assembly; aresilient proximal subshell connected to and extending flexiblyoutwardly from the proximal frame assembly, the proximal subshell havinga main body and a perimeter edge portion secured along the periphery ofthe main body, the perimeter edge portion being formed from a materialhaving less hardness than a material used to form the main body; whereinlateral and medial ends of the proximal strap are respectively directlyconnected to lateral and medial end portions of the proximal subshell.10. The knee brace according to claim 9, wherein the proximal frameassembly defines an upper proximal central portion, the proximalsubshell being centrally secured onto the upper proximal centralportion, the lateral and medial end portions of the proximal subshellextending outwardly from lateral and medial sides of the upper proximalcentral portion, respectively, so as to arcuately bend from the upperproximal central portion of the proximal frame assembly.
 11. The kneebrace according to claim 9, further comprising: a distal subshellconnected to and extending flexibly outwardly from the distal frameassembly, the distal subshell defining upper lateral and medial endportions extending arcuately from the distal frame assembly; an upperdistal strap having lateral and medial ends directly connected to theupper lateral and medial end portions, respectively, thereby connectingto lateral and medial sides of the distal frame assembly.
 12. The kneebrace according to claim 11, wherein the distal subshell forms a concavecurved crest located along an upper central section between the lateraland medial end portions thereof.
 13. The knee brace according to claim11, wherein the distal frame assembly includes distal lateral and medialsupports upon which the lateral and medial end portions of the distalsubshell are adjustably secured.
 14. The knee brace according to claim11, wherein the distal subshell defines lower lateral and medial endportions spaced by a lower central section and extending from a lowercentral portion of the distal subshell, the lower central portionsecured to a lower distal central support of the distal frame assembly,the lower lateral and medial end portions extending flexibly outwardlyfrom the lower distal central support; wherein the upper lateral andmedial end portions are spaced by lateral and medial clearances,respectively, from the lower lateral and medial end portions.
 15. Theknee brace according to claim 14, further comprising: a lower distalstrap having lateral and medial ends directly connected to the lowerlateral and medial end portions, respectively, thereby connecting to thelateral and medial sides of the distal frame assembly.
 16. The kneebrace according to claim 14, wherein the lower central section isanchored to the lower distal central support; wherein the distal frameassembly includes distal lateral and medial supports upon which thelateral and medial end portions of the distal subshell are adjustablysecured.
 17. The knee brace according to claim 14, wherein the distalsubshell has a main body and a perimeter edge portion secured along theperiphery of the main body, the perimeter edge portion being formed froma material softer than a material used to form the main body.
 18. Anorthopedic device, comprising: a rigid frame; a subshell connected toand extending flexibly outwardly from the rigid frame, the subshelldefining first and second end portions wherein the first end portion ispinned to the rigid frame, and the second end portion arcuately extendsrelative to the rigid frame; an elongate strap having at least one enddirectly connected to the second end portion, the strap urging thesecond end portion to bend relative to the rigid frame; wherein thesubshell has a main body and a perimeter edge portion secured along theperiphery of the main body, the perimeter edge portion being formed froma material softer than a material used to form the main body.
 19. Theorthopedic device according to claim 18, wherein the subshell defines anaperture generally located at the first end portion, the subshellfurther comprising a guard encircling the aperture and having a lipspaced above the main body and extending over a portion of the main bodytowards the aperture.
 20. The orthopedic device according to claim 19,wherein the guard is formed from a material more resilient than thematerial used to form the main body.